Pharmaceutical

TSX:CRDL

Cardiol Therapeutics

TSX:CRDL

A Clinical-stage life sciences company focused on the research and clinical development of anti-inflammatory therapies for the treatment of cardiovascular disease.

Company Highlights

  • Experienced leadership with extensive expertise in developing therapeutics for inflammatory heart disease
  • Research focused on the development of subcutaneous cannabidiol formulation for heart failure
  • Compelling evidence supporting cannabidiol’s anti-inflammatory and anti-fibrotic properties
  • Leader in developing cannabidiol as a therapy for the treatment of cardiovascular diseases
  • Phase II and Phase II/III trials of CardiolRx™ for acute myocarditis, recurrent pericarditis, and cardio-respiratory complications post SARS-CoV-2 infection
  • Comprehensive intellectual property portfolio
  • Strong financial position to support research and clinical development programs into 2024, with zero debt, plus cash and cash equivalents of about C$75m as of March 31, 2022.
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Overview

Cardiol Therapeutics (TSX:CRDL, NASDAQ:CRDL) is a clinical-stage life sciences company focused on the research and clinical development of cannabidiol as an anti-inflammatory and anti-fibrotic therapy for the treatment of cardiovascular diseases. The Company’s lead product candidate, CardiolRx™, is a pharmaceutically produced oral cannabidiol formulation that is being clinically developed for use in cardiovascular medicine. CardiolRx™ is currently being evaluated in a Phase II/III multi-national, randomized, double-blind, placebo-controlled study (the LANCER trial). LANCER is designed to evaluate the efficacy and safety of CardiolRx™ as a cardioprotective therapy to reduce major cardiovascular and respiratory events in patients hospitalized with COVID-19 who have a prior history of, or risk factors for, CVD, and to investigate the influence CardiolRx™ has on key biomarkers associated with heart disease.

Cardiol has also received IND authorization from the FDA to conduct clinical studies to evaluate the efficacy and safety of CardiolRx™ in two orphan drug indications: (i) a Phase II multi-national, randomized, double-blind, placebo-controlled trial in acute myocarditis, an important cause of acute and fulminant heart failure in young adults and the leading cause of sudden cardiac death in people less than 35 years of age; and (ii) a Phase II multicenter open-label pilot study in recurrent pericarditis (inflammation of the pericardium), which is associated with symptoms including debilitating chest pain, shortness of breath, and fatigue, and results in physical limitations, reduced quality of life, emergency department visits, and hospitalizations.

Additionally, Cardiol is developing a subcutaneous cannabidiol formulation targeting the inflammation and fibrosis associated with the development and progression of heart failure – a chronic condition estimated to affect 64 million globally and is a leading cause of death and hospitalization, with associated annual healthcare costs in the U.S. alone exceeding $30 billion.

In collaboration with researchers and opinion leaders at international centers of excellence, including the Houston Methodist DeBakey Heart & Vascular Center and the TecSalud del Tecnológico de Monterrey, Mexico, Cardiol is leveraging multidisciplinary expertise in drug delivery, drug formulation, cardiac physiology, and heart failure. The Company’s research collaborations provide Cardiol with the optimal platform on which to pursue the commercial development of new therapies for chronic heart failure, a leading cause of death and disability in the western world.

Cardiol’s management team has extensive experience in the research and commercial development of novel therapeutics. Additionally, insiders and employees are notably invested in the company, holding approximately 11 percent of the outstanding shares. The company expanded its board in May 2022, appointing Teri Loxam and Chris Waddick as directors.

Loxam brings over 25 years of experience in pharmaceutical and life sciences industries, with roles spanning from strategy to investor relations. Waddick has over three decades of experience in financial and executive roles in biotechnology and emerging industries. Per Chairman, Dr. Torre-Amione, “Their extensive and diversified experience will be invaluable to our continued growth and success as we advance the development of important new anti-fibrotic and anti-inflammatory therapeutics for the treatment of heart disease."

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Overview

Cardiol Therapeutics (TSX:CRDL, NASDAQ:CRDL) is a clinical-stage life sciences company focused on the research and clinical development of cannabidiol as an anti-inflammatory and anti-fibrotic therapy for the treatment of cardiovascular diseases. The Company’s lead product candidate, CardiolRx™, is a pharmaceutically produced oral cannabidiol formulation that is being clinically developed for use in cardiovascular medicine. CardiolRx™ is currently being evaluated in a Phase II/III multi-national, randomized, double-blind, placebo-controlled study (the LANCER trial). LANCER is designed to evaluate the efficacy and safety of CardiolRx™ as a cardioprotective therapy to reduce major cardiovascular and respiratory events in patients hospitalized with COVID-19 who have a prior history of, or risk factors for, CVD, and to investigate the influence CardiolRx™ has on key biomarkers associated with heart disease.

Cardiol has also received IND authorization from the FDA to conduct clinical studies to evaluate the efficacy and safety of CardiolRx™ in two orphan drug indications: (i) a Phase II multi-national, randomized, double-blind, placebo-controlled trial in acute myocarditis, an important cause of acute and fulminant heart failure in young adults and the leading cause of sudden cardiac death in people less than 35 years of age; and (ii) a Phase II multicenter open-label pilot study in recurrent pericarditis (inflammation of the pericardium), which is associated with symptoms including debilitating chest pain, shortness of breath, and fatigue, and results in physical limitations, reduced quality of life, emergency department visits, and hospitalizations.

Additionally, Cardiol is developing a subcutaneous cannabidiol formulation targeting the inflammation and fibrosis associated with the development and progression of heart failure – a chronic condition estimated to affect 64 million globally and is a leading cause of death and hospitalization, with associated annual healthcare costs in the U.S. alone exceeding $30 billion.

In collaboration with researchers and opinion leaders at international centers of excellence, including the Houston Methodist DeBakey Heart & Vascular Center and the TecSalud del Tecnológico de Monterrey, Mexico, Cardiol is leveraging multidisciplinary expertise in drug delivery, drug formulation, cardiac physiology, and heart failure. The Company’s research collaborations provide Cardiol with the optimal platform on which to pursue the commercial development of new therapies for chronic heart failure, a leading cause of death and disability in the western world.

Cardiol’s management team has extensive experience in the research and commercial development of novel therapeutics. Additionally, insiders and employees are notably invested in the company, holding approximately 11 percent of the outstanding shares. The company expanded its board in May 2022, appointing Teri Loxam and Chris Waddick as directors.

Loxam brings over 25 years of experience in pharmaceutical and life sciences industries, with roles spanning from strategy to investor relations. Waddick has over three decades of experience in financial and executive roles in biotechnology and emerging industries. Per Chairman, Dr. Torre-Amione, “Their extensive and diversified experience will be invaluable to our continued growth and success as we advance the development of important new anti-fibrotic and anti-inflammatory therapeutics for the treatment of heart disease."

Company Highlights

  • Experienced leadership with extensive expertise in developing therapeutics for inflammatory heart disease
  • Research focused on the development of subcutaneous cannabidiol formulation for heart failure
  • Compelling evidence supporting cannabidiol’s anti-inflammatory and anti-fibrotic properties
  • Leader in developing cannabidiol as a therapy for the treatment of cardiovascular diseases
  • Phase II and Phase II/III trials of CardiolRx™ for acute myocarditis, recurrent pericarditis, and cardio-respiratory complications post SARS-CoV-2 infection
  • Comprehensive intellectual property portfolio
  • Strong financial position to support research and clinical development programs into 2024, with zero debt, plus cash and cash equivalents of about C$75m as of March 31, 2022.

Key Projects

Orphan Drug Program for Acute Myocarditis

In June 2019, Cardiol announced its intent to complete a multi-national clinical trial for acute myocarditis, an inflammation of the heart muscle commonly caused by a viral infection of the heart tissue, utilizing its CardiolRx™ CBD formulation.

The most recent data from the Global Burden of Disease Study suggests a low prevalence of myocarditis, with studies showing its effects on between 10 and 20 cases in a 100,000 population, qualifying the condition as an orphan disease in the U.S. and in Europe. Benefits from orphan drug designation include marketing exclusivity rights, high reimbursement levels, and regulatory fast-tracking.

“The US orphan drug program was successfully utilized to accelerate the first FDA approval of CBD for the treatment of rare forms of pediatric epilepsy, and significant shareholder value was created in the process,” stated Cardiol President and CEO David Elsley. “Given the mortality and significant morbidity risk associated with acute myocarditis, we believe there is a similar opportunity in pursuing an expedited development program of our CardiolRx™ pharmaceutical CBD formulation for this serious orphan disease which has no accepted standard of care.”

Although the symptoms are often mild, myocarditis remains an important cause of acute and fulminant heart failure and is a leading cause of sudden cardiac death in people less than 35 years old. In addition, some patients proceed to develop chronic dilated cardiomyopathy which continues to be the leading indication for cardiac transplantation. Symptoms include chest pain, fatigue, shortness of breath, and arrhythmias. Because of the progressive damage to heart cells, heart failure develops due to the inability of the heart to pump sufficient blood to meet the body’s needs.

In November 2019, Cardiol announced the formation of the Clinical Steering Committee (CSC) for a Phase II international trial in acute myocarditis using the CardiolRx™ CBD formulation. The CSC is expected to provide oversight of the protocol, including amendments, and advice to investigators regarding all aspects of the trial.

The CSC is comprised of ten highly distinguished thought leaders in cardiology from the Cleveland Clinic, the Mayo Clinic, the Houston Methodist DeBakey Heart and Vascular Center, the University of Ottawa Heart Institute, McGill University Health Center, the University of Pittsburgh Medical Center, and Charité University Medicine Berlin, the Tel Aviv Medical Center, and Sao Paulo University Medical School.

In April 2021, Cardiol announced topline results from a Phase I single and multiple ascending dose clinical trial of CardiolRx™. Topline results demonstrated that CardiolRx™ was safe and generally well tolerated at all dose levels, with no serious adverse events reported in the study. The findings were consistent with published results for oral cannabidiol formulations and serve as a rationale for the dosing regimen that will be utilized in the Company’s planned Phase II program in acute myocarditis.

In August 2021, Cardiol announced that the FDA provided clearance to proceed with the company’s Investigational New Drug (IND) application to commence a Phase II, multi-center, double-blind, randomized, placebo-controlled trial, designed to study the safety and tolerability of CardiolRx™, as well as its impact on myocardial recovery in patients presenting with acute myocarditis. In October 2021, Cardiol received approval from Health Canada to commence a Phase II trial of CardiolRx™ in patients with Acute Myocarditis.

Cardiol’s acute myocarditis study is expected to enroll 100 patients at clinical centers in the United States, Canada, and Europe. The primary endpoints of the trial, which will be evaluated after 12 weeks of double-blind therapy, consist of the following cardiac magnetic resonance measures: left ventricular function (ejection fraction and longitudinal strain), and myocardial edema (extracellular volume. Each of these has been shown to predict long-term prognosis of patients with acute myocarditis.

Orphan Drug Program for Recurrent Pericarditis

In May 2022, Cardiol announced the U.S. FDA has authorized the Company’s IND to commence a Phase II open-label pilot study designed to evaluate the tolerance and safety of CardiolRx™ in patients with recurrent pericarditis. The study will also assess the improvement in objective measures of disease, and during an extension period, assess the feasibility of weaning concomitant background therapy including corticosteroids, while taking CardiolRx™.

The most recent data suggests a low prevalence of recurrent pericarditis, with a patient estimate of 38,000, thereby making CardiolRx™ eligible for orphan drug status under the FDA’s Orphan Drug Designation program.

Pericarditis refers to inflammation of the pericardium – the membrane, or sac, that surrounds the heart. Symptoms include debilitating chest pain, shortness of breath, and fatigue, which result in physical limitations, reduced quality of life, emergency department visits, and hospitalizations. Causes of pericarditis can include infection (e.g., tuberculosis), systemic disorders such as autoimmune and inflammatory diseases, cancer, and post-cardiac injury syndromes. Based on time of presentation, acute pericarditis is a symptomatic event lasting less than four to six weeks, the diagnosis of which is based on meeting two of four criteria: chest pain; pericardial rub; electrocardiogram changes; and new or worsening pericardial swelling. Although generally self-limited and not life-threatening, acute pericarditis is diagnosed in 0.2% of all cardiovascular in-hospital admissions and is responsible for 5% of emergency room admissions for chest pain in North America and Western Europe.

Recurrent pericarditis is the reappearance of symptoms after a symptom-free period of at least 4–6 weeks following an episode of acute pericarditis. These recurrences appear in 15% to 30% of acute cases and usually within 18 months. Further, up to 50% of patients with a recurrent episode of pericarditis experience more recurrences.

Cardiol’s study is expected to enroll 25 patients at major clinical centers specializing in pericarditis in the United States. The study protocol has been designed in collaboration with thought leaders in pericardial disease. The trial’s primary efficacy endpoint is the change, from baseline to 8 weeks, in patient-reported pericarditis pain using an 11-point numeric rating scale (NRS). The NRS is a validated clinical tool used across multiple conditions with acute and chronic pain, including previous studies of recurrent pericarditis. Secondary endpoints include the pain score after 26 weeks of treatment, and changes in C-reactive protein (CRP).

Dr. Andrew Hamer, Cardiol’s Chief Medical Officer commented, “We believe there is a significant opportunity to develop a new oral, well tolerated therapy for treating recurrent pericarditis to prevent multiple recurrences, for colchicine refractory, intolerant, and contraindicated patients, as well as steroid-dependent patients. With IND authorization now in place, we look forward to ramping up initiation of this important study. We also anticipate benefiting from the clinical trial infrastructure already established for our multi-national acute myocarditis study, which is expected to commence patient enrollment imminently.”

LANCER, a Phase II/III COVID-19 Trial

On April 28, 2021, Cardiol announced the enrollment of the first randomized patient in the LANCER trial, a Phase II/III multi-national study designed to evaluate the efficacy and safety of CardiolRx™ as a cardioprotective therapy to reduce major cardiovascular and respiratory events in 422 patients hospitalized with COVID-19 who have a prior history of, or risk factors for, CVD, and to investigate the influence CardiolRx™ has on key biomarkers associated with heart disease. The trial is taking place at major centers in the United States, and at centers in Brazil and Mexico where the prevalence of COVID-19 remains high.

In May 2022, Cardiol received clearance from the FDA and regulatory agencies in Brazil and Mexico. This expands the trial to include up to 20 additional clinical research centers. Cardiol projects that it will complete full patient enrollment during the second half of 2022.

Patients with COVID-19 primarily present with respiratory symptoms which can progress to bilateral pneumonia and serious pulmonary complications. It is now recognized that the impact of COVID-19 is not limited to the pulmonary system. Individuals with pre-existing CVD or who have risk factors for CVD, such as diabetes, hypertension, obesity, abnormal serum lipids, or age greater than 64, are at significantly greater risk of developing serious disease from COVID-19 and experience greater morbidity.

Such COVID-19 patients are at significant risk of developing cardiovascular complications (such as acute myocardial infarction, cardiac arrhythmias, myocarditis, stroke, and heart failure) during the course of their illness. These complications can be fatal, and result in an estimated 30-40% of all COVID-19 deaths. A strategy to prevent or limit the number or severity of these cardiovascular complications is likely to considerably improve outcomes from this disease.

Cardiol’s LANCER trial has been designed to assess the efficacy, safety, and tolerability of CardiolRx™ in preventing cardiovascular complications in hospitalized patients, with a confirmed diagnosis of COVID-19 within the previous 24 hours, and who have pre-existing CVD and/or significant risk factors for CVD. The composite primary efficacy endpoint will be the difference between the active and placebo groups in the percentage of patients who develop, during the first 28 days following randomization, and first dose of study medication, a composite endpoint consisting of one or more of several common outcomes in this patient population, including all-cause mortality, requirement for ICU admission and/or ventilatory support, as well as cardiovascular complications, including the development of heart failure, acute myocardial infarction, myocarditis, stroke, or new sustained or symptomatic arrhythmia.

“There is compelling evidence that inflammation plays a fundamental role in the development and progression of heart disease,” said Dr. Andrew Hamer, chief medical officer of Cardiol Therapeutics. “I am excited to see the initiation of the LANCER trial which will provide a unique opportunity to explore the anti-inflammatory and cardioprotective properties of CardiolRx™ in COVID-19 patients who are at high risk for major cardiovascular complications.”

Cardiol Therapeutics’ Heart Failure Program

People with heart failure suffer from a variety of ailments, including shortness of breath, rapid heart rate, edemas, reduced exercise capacity. This can often result in a struggle with simple daily activities, causing frequent hospitalization. Many of these symptoms can significantly reduce the quality of life for an individual.

There are two types of heart failure: systolic and diastolic. Systolic heart failure, or heart failure with reduced ejection fraction (HFrEF), occurs when the left ventricle cannot adequately pump blood from the heart and into circulation. Diastolic heart failure, or heart failure with preserved ejection fraction (HFpEF), occurs when the left ventricle becomes stiff and does not relax as it should; and, as a result, cannot fill properly, causing pressure to build in the left side of the heart and in the lungs. This results in a patient feeling shortness of breath and is associated with health concerns such as obesity, hypertension, and diabetes.

Another complication that can be experienced by those suffering from HFpEF is chronic inflammation, which can lead to a decrease in blood vessel function, impairment of heart muscle function, and fibrosis, which results in stiffness in the heart and a reduction in pumping efficiently. Over the past 20 years, there have been little to no significant treatments developed for HFpEF, as therapies have primarily remained focused on diuretics.

Cardiol is developing a subcutaneous cannabidiol formulation targeting the inflammation and fibrosis associated with the development and progression of heart failure – a chronic condition estimated to affect 64 million globally and is a leading cause of death and hospitalization, with associated annual healthcare costs in the U.S. alone exceeding $30 billion.

This subcutaneous formulation would be a new approach to the treatment of chronic heart failure based on the anti-inflammatory activity of cannabidiol to treat inflamed heart tissue and the anti-fibrotic activity of cannabidiol to treat fibrosis (scarring) in heart muscle.

Published third-party research has shown that cannabidiol reduces inflammatory activation of the endothelial lining of blood vessels and aids endothelial vasorelaxation, resulting in improved blood flow. Cannabidiol has also been shown to attenuate a number of measures of inflammation in models of diabetes, a common comorbidity in heart failure patients, and to reduce myocardial fibrosis in a model of inflammatory heart disease.

Cannabidiol is lipid soluble, virtually insoluble in water, highly sensitive to deactivation in the liver via first-pass metabolism when taken orally, and is rapidly cleared from the body. This results in a low overall bioavailability when taken orally. Cardiol’s subcutaneous administration of cannabidiol is designed to minimize first-pass metabolism, optimize, and maintain blood levels of the drug, and target inflammation and increased fibrosis in the heart. Cardiol believes that overcoming the low bioavailability issues associated with cannabidiol will significantly broaden the therapeutic potential of this molecule.

Cardiol Therapeutics’ Strategic Partnership

Dalton Pharma Services

Cardiol has established an exclusive manufacturing arrangement with Dalton Pharma for the supply of pharmaceutical cannabidiol for Cardiol’s research programs using CardiolRx™.

Located in Toronto, Dalton is a Health Canada approved, FDA registered, cGMP manufacturer of over 200 Active Pharmaceutical Ingredients (APIs), including pharmaceutical cannabinoids, with manufacturing capability scalable to support all stages of the regulatory process (Phase I, II, III, and commercial).

In 2016 and 2017, Dalton Pharma received the Leadership Award for Contract Manufacturing Organizations (CMO) in the following categories: quality, capabilities, expertise, compatibility and development. Dalton is also the manufacturer of Nabilone, the largest prescription pharmaceutical cannabinoid in the world, with annual sales of C$100 million. As part of the partnership, Dalton is also a significant shareholder in Cardiol. Dalton’s founder, owner and CEO, Peter Pekos, is on Cardiol’s board.

Cardiol Therapeutics’ Research Collaborations

DeBakey Heart and Vascular Center

Cardiol is conducting experimental research at the Houston Methodist DeBakey Heart & Vascular Center, designed to investigate the activity of the company’s proprietary subcutaneous cannabidiol formulation in a model of heart failure.

The Houston Methodist DeBakey Heart & Vascular Center is recognized internationally as a center of excellence for the treatment of heart failure. The center was the birthplace of cardiovascular bypass surgery in 1964 and is currently ranked the 15th best hospital for care in cardiology and heart surgery out of 592 hospitals in the United States.

TecSalud del Tecnológico de Monterrey

Cardiol is collaborating with TecSalud del Tecnológico de Monterrey (TecSalud) and DeBakey Heart & Vascular Center on research and development of a proprietary subcutaneous cannabidiol formulation for the treatment of heart failure. The primary objective of this collaboration is to develop the experimental evidence necessary to support advancing breakthrough treatments for heart failure into clinical development.

Management Team

David Elsley, MBA - President, CEO and Director

Founder and CEO of Vasogen Inc., with 25 years of experience developing, financing and managing all aspects of corporate development of biotechnology and high-growth organizations.

Andrew Hamer, MB, ChB - Chief Medical Officer

Former Executive Director at Amgen Inc., responsible for leading global development for Repatha®, former Chief Cardiologist at Nelson Hospital, New Zealand. 19 years of experience practicing Cardiology and Internal Medicine.

Chris Waddick, MBA, CPA, CMA - Chief Financial Officer

Thirty years of experience in financial and executive roles in the biotechnology and energy industries, former Chief Financial Officer and Chief Operating Officer of Vasogen Inc.

Bernard Lim, MIET, CEng (UK) - Chief Operating Officer

Thirty years in the life sciences industry spanning biotechnology, diagnostics, medical devices, and high-technology. Founder and CEO of a highly successful drug delivery company that he led from R&D through to commercialization and its eventual acquisition by Eli Lily.

Anne Tomalin, BA, B.Sc., RAC - Director of Regulatory Affairs

Founder of CanReg Inc and TPIreg, regulatory firms previously sold to Optum Insight and Innomar Strategies respectively. An expert in regulatory affairs in Canada, United States and Europe.

Andrea B. Parker, MSc, PhD - Director of Clinical Affairs

Chief Scientific Officer at Peter Munk Cardiac Centre, University Health Network. Clinical Epidemiologist with more than 30 years’ experience in clinical trials design, management, and execution in industry and academic settings.

Blagoja Ristevski, B.Sc., CHE - Director of Chemical Engineering and Manufacturing

Chemical Engineer, 25+ years of experience in the biopharmaceutical industry, senior exec. roles in eight Canadian biopharmaceutical Co.’s in the research/discovery of drug products; VP Product Dev., AMRIC Institute, Ontario, Canada.

Board of Directors

Guillermo Torre-Amione – Chairman

Guillermo Torre is the president of TecSalud academic medical center and school of the Instituto Tecnológico y de Estudios Superiores de Monterrey (ITESM), Mexico. He is the former director of Cardiac Transplantation at the Houston Methodist DeBakey Heart & Vascular Center.

David Elsley – President, Chief Executive Officer, and Director

David Elsley is the founder and CEO of Vasogen Inc. and has an MBA degree. Elsley has over 25 years of experience developing, financing, and managing all aspects of corporate development in biotechnology and high-growth organizations.

Jennifer M. Chao – Director

Jennifer M. Chao has over 25 years of experience in the biotech and life sciences industries, focused primarily on finance and corporate strategy. Chao is managing Partner of CoreStrategies Management, a company she founded in 2008 to provide transformational corporate and financial strategies to biotech and life science companies with a view to maximizing core valuation. She currently serves on the board of directors of Endo Pharmaceuticals and is a member of the audit committee and compliance committee. Prior to joining Endo, Chao served as chairman of the board of BioSpecifics Technologies from October 2019, until its acquisition by Endo for approximately US$660 million in December 2020. She also served as chair of BioSpecifics' compensation committee and as a member of the audit committee, strategy committee, intellectual property committee, and nominating and corporate governance committee from 2015 to 2020.

Peter Pekos – Director

President and CEO at Dalton Pharma, Peter Pekos has broad experience in research, development, and commercialization of pharmaceuticals, products, and services.

Colin Stott – Director

Colin Stott has over 30 years of experience in pre-clinical and clinical development, with specific expertise in the development of cannabinoid-based medicines. Stott is the chief operating officer of Alinova Biosciences and the former scientific affairs director, international, and research and development operations director for GW Pharmaceuticals, a world leader in the development of cannabinoid therapeutics.

Chris Waddick – Chief Financial Officer and Director

Chris Waddick has an MBA degree, is a chartered professional accountant, and a certified management accountant. He has over 30 years of experience in financial and executive roles in the biotechnology and energy industries. Waddick is the former chief financial officer and chief operating officer of Vasogen Inc.

Teri Loxam – Director

Teri Loxam has over 25 years of experience in biotech, life sciences and entertainment industries with diverse roles spanning strategy, investor relations, finance and communications. Loxam is the Chief Operating Officer and Chief Financial Officer of Kira Pharmaceuticals. In this role, she oversees finance, operations and strategic functions for the company. Prior to joining Kira, Ms. Loxam served as SQZ Biotech’s Chief Financial Officer where she led the company’s financial operations, investor relations and communications/public relations functions. While at SQZ, she was instrumental in helping the company raise over $200M in private and public funding, including taking the company public through an IPO on the NYSE in October 2020.

Michael J. Willner – Director

Michael J. Willner has practiced as both an attorney and a certified public accountant. He graduated from Emory University Law School as a member of the Emory Law Review. Subsequently, he practiced real estate and corporate law with New York City-based Milbank, Tweed, Hadley & McCloy, one of the nation’s most prominent international law firms. Prior to his legal career, Willner was employed by the former Arthur Andersen & Company, a national accounting firm, where he practiced in the tax department.

Scientific Advisory Board

Dr. Paul M. Ridker, MD, MPH

Dr. Paul M. Ridker is director of the Center for Cardiovascular Disease Prevention, a translational research unit at Brigham and Women’s Hospital in Boston (BWH). A cardiovascular medicine specialist, he is also the Eugene Braunwald Professor of Medicine at Harvard School of Medicine (HSM). Dr. Ridker received his medical degree from HSM, and then completed an internal medicine residency and a cardiology fellowship at BWH. He is board certified in internal medicine. Dr. Ridker’s clinical interests include coronary artery disease and the underlying causes and prevention of atherosclerotic disease. He is the author of over 900 peer-reviewed publications and reviews, 64 book chapters, and six textbooks related to cardiovascular medicine.

His primary research focus has involved inflammatory mediators of heart disease and the molecular and genetic epidemiology of hemostasis and thrombosis, with particular interests in biomarkers for coronary disease, predictive medicine, and the underlying causes and prevention of atherosclerotic disease. Ridker has been the principal investigator or study chairman of several large international trials that have demonstrated the role of inflammation in the genesis and management of coronary artery disease. He was included in TIME magazine’s list of 100 most influential people of 2004; and, between the years 2000 and 2010, Dr. Ridker was among the 10 most often cited researchers in cardiovascular medicine worldwide. He received the American Heart Association Distinguished Scientist Award in 2013, gave the Braunwald Lecture of the American College of Cardiology in 2019, was awarded the Gotto Prize for Atherosclerosis Research from the International Atherosclerosis Society in 2021, and is an elected Member of the National Academy of Medicine (USA).

Dr. Bruce McManus, PhD, MD

Dr. Bruce McManus is professor emeritus of the Department of Pathology and Laboratory Medicine at the University of British Columbia. He has served as CEO of the Center of Excellence for Prevention of Organ Failure (PROOF Center), director of the UBC Center for Heart and Lung Innovation, and scientific director, Institute of Circulatory and Respiratory Health, CIHR. Dr. McManus received BA and MD degrees from the University of Saskatchewan, an MSc from Pennsylvania State University, and a PhD from the University of Toledo. Dr. McManus pursued post-doctoral fellowships at the University of California, Santa Barbara in environmental physiology and at the National Heart, Lung, and Blood Institute in Bethesda. McManus served as MD in cardiovascular and pulmonary pathology, and completed residency training at the Peter Bent Brigham Hospital, Harvard University, in Internal Medicine and Pathology.

Dr. McManus’ investigative passion relates to mechanisms, consequences, detection, and prevention of injury, and in aberrant repair in inflammatory diseases of the heart and blood vessels. He has had a longstanding interest in the diagnosis and management of acute viral myocarditis. His life’s scholarship is reflected in more than 400 original peer-reviewed publications, over 60 chapters, and several books. Dr. McManus has been widely appreciated for his research, mentoring, and leadership contributions to the health sciences. Among many awards and honours, Dr. McManus received the prestigious Max Planck Research Award in 1991, was elected a Fellow of the Royal Society of Canada in 2002, was appointed a Member of the Order of Canada in 2018, and to the Order of British Columbia in 2019.

Dr. Joseph A. Hill, MD, PhD

Dr. Joseph A. Hill is professor of internal medicine and molecular biology, chief of cardiology at UT Southwestern Medical Center, in Dallas, and is the director of the Harry S. Moss Heart Center. Dr. Hill holds both the James T. Willerson, MD, distinguished chair in cardiovascular diseases, and the Frank M. Ryburn Jr. Chair in Heart Research. He graduated from Duke University with an MD and a PhD in 1987. Dr. Hill’s PhD dissertation research was in the field of cardiac ion channel biophysics. He then worked for five years as a postdoctoral fellow at the Institut Pasteur in Paris, studying central and peripheral nicotinic receptors. He next completed an internal medicine internship and residency, as well as a clinical cardiology fellowship, at the Brigham and Women’s Hospital, Harvard Medical School.

Dr. Hill served on faculty at the University of Iowa for five years before moving in 2002 to UT Southwestern. His research examines molecular mechanisms of structural, functional, metabolic, and electrophysiological remodeling in cardiac hypertrophy and heart failure. He has served on many NIH panels and committees, and delivered numerous invited lectures in the US and around the world. Dr. Hill has received many recognitions and awards, including election to the Association of American Professors and the 2018 Research Achievement Award from the International Society for Heart Research. For the past six years, Dr. Hill has been the editor in chief of the prestigious American Heart Association journal circulation.

*Disclaimer: This profile is sponsored by Cardiol Therapeutics ( TSX:CRDL ). This profile provides information which was sourced by the Investing News Network (INN) and approved by Cardiol Therapeutics in order to help investors learn more about the company. Cardiol Therapeutics is a client of INN. The company's campaign fees pay for INN to create and update this profile.

INN does not provide investment advice and the information on this profile should not be considered a recommendation to buy or sell any security. INN does not endorse or recommend the business, products, services or securities of any company profiled.

The information contained here is for information purposes only and is not to be construed as an offer or solicitation for the sale or purchase of securities. Readers should conduct their own research for all information publicly available concerning the company. Prior to making any investment decision, it is recommended that readers consult directly with Cardiol Therapeutics and seek advice from a qualified investment advisor.

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